What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? -Answer- Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: -...
ACRP CP PRACTICE EXAM GUIDE 2024
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? -Answer- ✔Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must
conform to the established requirements for: -Answer- ✔Validation, accuracy, reliability,
completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to -
Answer- ✔maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the: -
Answer- ✔ICF
What document would an investigator reference to learn more about the previous
clinical and nonclinical results of studies of the IP? -Answer- ✔Investigators brochure
During a multi site clinical study, whose responsibility is it to report subject recruitment
rate? -Answer- ✔The CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an
LAR, and protocol therapy was initiated. The subject showed significant improvement in
his clinical condition, and regained consciousness. The Investigator should inform the
subject about the study and -Answer- ✔Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial, and has received
IRB approval. The site can begin enrolling subjects after... -Answer- ✔A signed clinical
trial agreement between the site and sponsor is in place
A site is screening potential subjects for a study looking at mild cognitive impairment.
One of the inclusion criteria is a score of 25 or less on a psychometric test, a research
specific tool which measures cognitive ability. Which of the following individuals can
administer the psychometric test to the potential subjects? -Answer- ✔A research
assistant who is certified to administer the psychometric test
A research study, in which there is no intended clinical benefit to the subject, is being
submitted to the IRB. What benefit informatiom should be included in the ICF? -Answer-
✔Wording indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is
prior to the effective date indicated on the cover page of the protocol and the signatures
of the investigator and sponsor. What should the CRA do FIRST? -Answer- ✔Confirm
dates of initial receipt of the sponsor protocol and the IRB submission dates.
ACRP CP PRACTICE Exam
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